Multi-channel flexible laryngeal mask airway device
Airway devices, systems, and methods are provided that can achieve ventilation of lungs through a mask that seals around the glottis and connects to a flexible airway channel, while also providing evacuation of gastric and/or pharyngeal body fluid and/or blood during upper airway surgeries or procedures.
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The present disclosure relates to a multi-channel airway device for surgeries and procedures involving the human upper airway.
BACKGROUNDUse of laryngeal mask airway devices for upper airway surgeries has been accepted as an alternative to the use of endotracheal tubes. A reinforced flexible laryngeal mask is generally preferred because its flexible, longer and thinner airway channel offers better access to the surgical field than other types of laryngeal mask. When placed properly, a laryngeal mask covers the glottis and protects the glottis and subglottic area from contamination with blood or other fluids that accumulates in the pharynx during upper airway surgery. However, the glottic seal formed by the mask is variable and dynamic, depending on numerous factors. As a result, aspiration due to leaking of blood or other fluids into the glottic area and the trachea has been reported in cases of laryngeal mask use during upper airway surgeries. In addition, the flexible laryngeal mask, like other first-generation laryngeal masks, typically does not prevent gastric insufflation during positive pressure ventilation, which is generally believed to lead to a higher risk of aspiration of gastric contents and subsequent complications. As a result, safety concerns surrounding the application of flexible laryngeal masks in upper airway surgeries persist in general. Furthermore, leaking of blood into the stomach may cause gastric irritation and possible increased incidence of postoperative nausea and vomiting.
SUMMARYExemplary embodiments of the present disclosure relate to airway devices, systems, and associated methods. Embodiments of the airway devices, systems, and methods can achieve ventilation of lungs through a mask that seals around the glottis and connects to a flexible airway channel, while also providing evacuation of gastric and/or pharyngeal body fluid and/or blood through a channel-ampulla-drain system integrated with the mask during upper airway surgeries or procedures. Exemplary embodiments of the present disclosure can improve the safety of airway management and lung ventilation for upper airway surgeries. For example, embodiments of the present disclosure can minimize the risk of aspiration of blood or other fluid accumulated in the pharynx as well as the risk of aspiration of gastric contents during upper airway surgeries.
In accordance with embodiments of the present disclosure, a laryngeal mask airway system is disclosed. The system includes an airway channel portion including an airway channel and a mask portion operatively coupled to the airway channel portion via an airway channel-mask junction. The mask portion includes a mask and an ampulla. The ampulla is disposed at a distal end of the mask portion and includes ports. The mask portion can also include a pharyngeal suction channel and/or a gastric-pharyngeal access channel. For embodiments that include the pharyngeal suction channel, the pharyngeal suction channel can extend through the mask portion from the airway channel-mask junction and terminate at one of the upper ports the ampulla. For embodiments that include the gastric-pharyngeal access channel, the gastric-pharyngeal access channel originates with an opening at a proximal end of the mask portion in proximity to the airway channel-mask junction and terminates at one of the upper ports of the ampulla. A ramp can be formed on the mask that slopes towards the opening of the gastric-pharyngeal access channel. The gastric-pharyngeal access channel can have an oval cross-sectional shape.
A lower port of the ampulla can be opposingly spaced from the upper port associated with the gastric-pharyngeal access channel and can open towards an esophagus of a human when the mask portion is placed in the hypopharynx of the human. This lower port can have a funnel-shape with first cross-sectional dimensions at the ampulla and second cross-sectional dimensions at a distal end of the lower port. A first cross-sectional area of the lower port at the ampulla is greater than the second cross-sectional area of the lower port at the distal end of the lower port. The distal end of the lower port can include a valve, which can be formed by a plurality of leaflets. In a closed position, adjacent ones of the plurality of leaflets of the valve engage each other to form a center opening. The gastric-pharyngeal access channel can have a third cross-sectional area that is greater than the cross-sectional area of the lower port opposing the upper port connected to the gastric-pharyngeal access channel.
In accordance with embodiments of the present disclosure, the system can include at least one pharyngeal drain formed on the mask. The at least one pharyngeal drain can be operatively coupled to one of the ports of the ampulla. For embodiments, that include a second pharyngeal drain, the second pharyngeal drain can be operatively coupled to another one of the ports of the ampulla.
In accordance with embodiments of the present disclosure, the system can include a pharyngeal suction channel that extends from a proximal end of the airway channel portion to the fourth port of the ampulla. A first portion of the pharyngeal suction channel can be formed within or outside of the airway channel and a second portion of the pharyngeal suction channel can be formed within the mask. The first portion of the pharyngeal suction channel can be formed by a suction catheter. For embodiments in which the first portion of the of the pharyngeal suction channel is formed outside the airway channel, the first portion can be attached to the airway channel portion or separate from the airway channel.
In accordance with embodiments of the present disclosure, the system can include a dual suction tube having a lower section, an upper section, and a transitional zone between the lower and upper sections. The lower section can include at least one eyelet disposed at a distal end of the lower section. The upper section can include at least one port configured to be connect to a vacuum source. The transitional zone can be disposed between the lower and upper section. The transitional zone can have a first cross-sectional area proximate the proximal end of the transitional zone and a second cross-sectional area proximate to the distal end of the transitional zone, wherein the first cross-sectional area is greater than the second cross-sectional area such that proximal end of the transitional zone is larger than a distal end of the transitional zone. The transitional zone can include at least one eyelet, which can be disposed proximate to the distal end of the transitional zone.
The lower section of the dual suction tube can be configured and dimensioned to be inserted in and passed through the gastric-pharyngeal access channel, the upper port connecting the gastric-pharyngeal access channel to the ampulla, the ampulla, and the lower port opposingly spaced from the upper port. The upper section and/or the transitional zone can be configured and dimensioned to be inserted in and passed through the gastric-pharyngeal access channel, the upper port connecting the gastric-pharyngeal access channel to the ampulla, and the ampulla, however, the transitional zone can be configured and dimensioned to engage, or to be inserted in but not to be passed through, the lower port of the ampulla because the distal part of the lower port can be dimensioned to prevent the transitional zone from passing through. The dual suction tube can be configured and/or dimensioned to be inserted into the mask portion via the gastric-pharyngeal channel until the transitional zone engages the lower port of the ampulla and stops the advancement of the dual suction tube.
The at least one eyelet disposed near the distal end of the transitional zone can be blocked when the transitional zone is engaged with the lower port of the ampulla. The dual suction tube can include an inner (air) lumen that forms an air vent and a gastric lumen. In some embodiments, the dual suction tube can include a pharyngeal lumen. The gastric lumen extends a length of the dual suction tube. The inner lumen can be disposed within the gastric lumen.
In accordance with embodiments of the present disclosure, for embodiments that include the pharyngeal lumen, the pharyngeal lumen can extend from a proximal end of the dual suction tube to the transitional zone. The pharyngeal lumen can include at least one eyelet disposed at a distal end of the pharyngeal lumen which is configured to be positioned in the ampulla when the dual suction tube is inserted into the mask portion. The dual suction tube can have an oval cross-section shape in the upper section that is defined by the gastric lumen and the pharyngeal lumen and can have a circular cross-sectional shape in the lower section defined by the gastric lumen. The pharyngeal lumen has at least one eyelet, which can be disposed in the pharyngeal lumen proximate a distal end of the pharyngeal lumen. The gastric lumen and the pharyngeal lumen can each have a port at the proximal end of the dual suction tube, wherein each port is configured to be connected to a separate vacuum source.
In accordance with embodiments of the present disclosure, the dual suction tube can be configured to be withdrawn a specified distance from the mask portion to align the at least one eyelet of the transitional zone with the ampulla to place the eyelet of the transitional zone of the dual suction tube in fluid communication with the ampulla.
Other objects and features will become apparent from the following detailed description considered in conjunction with the accompanying drawings. It is to be understood, however, that the drawings are designed as an illustration only and not as a definition of the limits of the invention.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the present disclosure and together with the description, serve to explain the principles of the disclosure.
Exemplary embodiments of the present disclosure relate to airway devices, systems, and methods that can achieve ventilation of lungs through a mask that seals around the glottis and connects to a flexible airway channel, while also providing evacuation of gastric and/or pharyngeal body fluid and/or blood during upper airway surgeries or procedures. Exemplary embodiments of the present disclosure can improve the safety of airway management and lung ventilation for upper airway surgeries. For example, embodiments of the present disclosure can minimize the risk of aspiration of blood or other fluid accumulated in the pharynx as well as the risk of aspiration of gastric contents during upper airway surgeries.
The mask portion 100 can include a mask 110 defined as a pear-shaped, dome-like structure having the base 101, an apex 102, and a torso 103 disposed between the base 101 and the apex 102. The mask 110 can be dimensioned and configured to fit within the upper airway of a human to cover and/or seal around the glottis of the human. The dome-like structure of the mask 110 can form a convex surface for a posterior side of the mask 110 which faces towards a posterior pharynx of a human when the mask portion 100 is positioned in the hypopharynx and can form a generally concave surface for an anterior side of the mask 110 which faces towards a larynx or glottis of a human when the mask portion 100 is positioned in the hypopharynx. The mask portion 100 can include a membrane cuff or other cushion material 130 that surrounds a perimeter of the mask 110. The mask portion 100 can extend along a centerline 104 from a first end defined by the mask-airway channel junction 13 to a second end defined by the distal end 12 of the mask portion 100. The first or proximal end of the mask portion 100 can be connected to or integrally formed with the airway channel portion 200 and can include an opening that is in fluid communication with an interior volume of an airway channel 210 of the airway channel portion 200 to form the mask-airway channel junction 13. The first or proximal end of the mask portion 100 can be oriented towards a mouth of a human when the mask portion 100 is positioned in the hypopharynx. The second or distal end of the mask portion, which forms the distal end 12 of the airway device 10 or 10′, can be oriented towards an esophagus of a human when the mask portion 100 is positioned within the hypopharynx. In exemplary embodiments, the mask portion 100 can include a pharyngeal suction channel 140, a gastric-pharyngeal (or gastropharyngeal) access channel 150, pharyngeal drains 160, and an ampulla 170 as described herein. The pharyngeal suction channel 140, the gastric-pharyngeal access channel 150, the pharyngeal drains 160, and the ampulla 170 can be formed on and/or embedded within the mask 110.
The airway channel portion 200 extends from the proximal end 11 to the mask-airway channel junction 13 and can include the airway channel 210. The proximal end 11 of the airway devices 10 and 10′ includes an opening 211 to the interior volume of the airway channel 210. The second or distal end of the airway channel 210 connects to or is integrally formed with the mask 110 of the mask portion 100 at the mask-airway channel junction 13. The airway channel 210 can be a flexible tubular structure that is reinforced with wires. For example, the airway channel 210 can include an embedded coil wire extending a length of the airway channel 210 such that the airway channel 210 is flexible, but provides resistance to radially inward deformation of the airway channel 210. In exemplary embodiments, the airway channel 210 can have an internal diameter of approximately 5 millimeters to approximately 11 millimeters or approximately 7 millimeters to approximately 9 millimeters with a length of approximately 18 centimeters to approximately 30 centimeters or approximately 22 centimeters to approximately 26 centimeters for adults. In exemplary embodiments, the airway channel 210 can have an internal diameter of approximately 4 millimeters to approximately 7 millimeters or approximately 4.5 millimeters to approximately 6.5 millimeters with a length of approximately 14 centimeters to approximately 21 centimeters or approximately 15 centimeters to approximately 20 centimeters for children.
As shown in
As shown in
In an exemplary application, the airway device 10 or 10′ can be inserted into the upper airway of a human such that the mask portion 100 is positioned in the hypopharynx of the human and the airway channel portion 200 extends from the mask portion such that the free terminal end of the airway channel 210 (i.e., the proximal end 11 of the airway device 10 or 10′) is positioned outside of a mouth of the human. When the airway device 10 or 10′ is positioned in the upper airway of the human, the airway device 10 or 10′ can allow access to the upper airway of the human for surgeries or procedures involving the upper airway. When the airway device 10 or 10′ is positioned in the upper airway of the human, the airway device 10 or 10′ can facilitate ventilation of lungs through the mask 110 and the flexible thin airway channel 210, while also providing evacuation of gastric and/or pharyngeal body fluid and/or blood during upper airway surgeries or procedures through two evacuation systems embedded in and integrated with the airway device, that is, through a first evacuation system formed by the gastric-pharyngeal access channel 150, the pharyngeal drains 160, and the ampulla 170, and a second evacuation system formed by the pharyngeal suction channel 140, the pharyngeal drains 160, and the ampulla 170. Therefore, the airway devices 10 and 10′ can improve the safety of airway management and lung ventilation for upper airway surgeries, for example, by minimizing the risk of aspiration of blood or other fluid accumulated in the pharynx as well as minimizing the risk of aspiration of gastric contents.
In an exemplary application, referring to
In an exemplary application, referring to
The apex 102 (e.g., proximate to the second end or lower part defined at the distal end 12) of the mask 110 encloses the ampulla 170, which includes ports 171-175. The ampulla can be an enclosed chamber or cavity accessible via the ports 171-175 which can form openings to the interior volume of the ampulla 170. The ampulla can have a generally bulbous or spherical internal volume. For embodiments of the mask portion that do not include the gastric-pharyngeal access channel 150, the ampulla 170 can be devoid of the port 175, as shown in
The pharyngeal suction channel 140 can be formed on or integrated with the mask 110, and can extend from the upper port 174 of the ampulla to the base 101 of the mask. The pharyngeal suction channel 140 can be embedded within the back of the mask and travel along the spine of the mask (
The gastric-pharyngeal access channel or gastropharyngeal channel 150 can be formed on or embedded in and integrated with the mask 110, and can extend from an opening 151 on the back of the mask, proximate to the first or proximal end (e.g. near the base 101) of the mask portion, to the upper port 175 of the ampulla 170 in the apex 102 of the mask 110. The gastric-pharyngeal access channel 150 can travel along the spine of the mask and enter the ampulla 170 at the upper port 175 to face the lower or distal port 171, which opens to the upper esophagus when the airway device is properly positioned in the hypopharynx of a human. In one embodiment, the gastric-pharyngeal access channel 150 itself (as shown in
The gastric-pharyngeal access channel 150 can be configured and dimensioned to receive a gastric suction tube or gastric-pharyngeal dual suction tube (DST) as described herein. For example, a cross-sectional area of the gastric-pharyngeal access channel 150 can be configured and dimensioned to allow for the passage of an appropriately sized gastric suction tube or gastric-pharyngeal dual suction tube DST (e.g. a size 12-18F for an adult). As an example, to accommodate a size 12-18F tube, the cross-sectional dimensions of the combined gastric-pharyngeal access channel 150 can be approximately five (5) millimeters by approximate eight (8) millimeters. In exemplary embodiments, the gastric-pharyngeal access channel can have generally oval cross-sectional shape.
A ramp 152 can be formed on the back of the mask from mask-airway channel junction 13 to the opening 151 of the gastric-pharyngeal access channel 150. The ramp 152 provides a guide for entry to the proximal opening 151 of the gastric-pharyngeal access channel 150. The ramp can be as a shallow recess formed in the back of the mask at the base 101 of the mask. The depth of the recess can gradually increase towards the opening 151 until the ramp 152 reaches the opening 151 at which point the depth of the recess of the ramp 152 can generally correspond to a depth of a bottom portion of the opening 151.
The pharyngeal drains 160 can be formed on or in the back of the mask 110. The pharyngeal drains 160 can extend along the side edges of the mask 110 from base 101 of the mask 110 towards the apex 102 of the mask 110. For example, the pharyngeal drains 160 can originate at the top of the mask 110, on the sidewalls of the mask 110 near the airway channel-mask junction 13 as small and shallow grooves or recesses. The pharyngeal drains 160 can gradually increase in width and depth before merging into the side ports 172 and 173 of the ampulla 170 near the apex 102 of the mask to form an ampulla-pharyngeal drain system. When the mask portion is positioned in the hypopharynx to cover and/or seal around the glottis, pharyngeal body fluid and/or blood can be collected by pharyngeal drains 160 during upper airway surgeries or procedures and can flow into the ampulla 170 where it can be removed through the pharyngeal suction channel 140 or using a suction tube via the gastric-pharyngeal access channel 150 as described herein. The high origination of the pharyngeal drains 160 provides air entry to the ampulla-pharyngeal drain system during suction, thereby preventing vacuum injury to the pharyngeal mucosa.
In some embodiments, the ampulla 170 can include a distal valve 176 covering the distal opening of the port 171 (
As shown in
The DST 400 can include two lumens: the main or suction lumen 410 and the air lumen 420. The main lumen 410 is larger than the air lumen 420 and is the working lumen for suction and evacuation of bodily fluids. The proximal end of the main lumen 410 terminates as a three-way port 413, which allows for vacuum suction only through hand regulation and avoids continuous suction which may cause injury to the gastric mucosa. The air lumen 420 provides an air vent, which allows for atmospheric air to enter the tube through a proximal port 421 and equalize the vacuum pressure once the contents are removed, preventing vacuum injury to the mucosa.
The lower (gastric) section 401 can be configured and dimensioned to fit and pass through the gastric-pharyngeal access channel 150 as well as the funnel-shaped distal port 171 of the ampulla 170 of the airway devices 10, 10′, and 30. For embodiments in which the distal port 171 includes the tri-leaflet valve 176, the lower section 401 can be configured and dimensioned to fit and pass through the tri-leaflet valve 176 to urge the tri-leaflet valve 176 to transition from its closed position to its open position. In exemplary embodiments, the lower section 401 can be approximately thirty-eight (38) centimeters to approximately forty-two (42) centimeters in length or approximately forty (40) centimeters in length. When the lower section 401 is positioned properly in the airway device 10 or 10′ or 30 that is placed in the hypopharynx of a human, approximately fifteen (15) centimeters of the lower section 401 can be left in the stomach of an adult human.
The upper (pharyngeal) section 402 and the transitional zone 403 can be configured and dimensioned to fit and pass through the gastric-pharyngeal access channel 150. However, as shown in
Referring to
As described herein, the DST 400 can have two sets of suction eyelets: the gastric eyelets 411 and the pharyngeal eyelets 412. The first set or gastric eyelets 411 are located at the distal end of the tube, approximately 40 cm from the transitional zone 403, and are used for evacuating fluids from the stomach. The second set or pharyngeal eyelets 412 are located in the truncated cone-shaped transitional zone 403, about 35 cm from the proximal end, and are used for evacuating fluids from the pharynx through the ampulla-pharyngeal drains. As shown in
With reference to
While
As shown in
The gastric lumen 510 can be the first and largest lumen, and is the working lumen for suction and evacuation of fluids from the stomach. The air lumen 520 can be the second and smallest lumen. Similar to air lumen 420 in DST 400, the air lumen 520 is for air vent—it travels along the gastric lumen and allows for atmospheric air to enter the stomach through a proximal port 521 and equalize the vacuum pressure once the gastric contents are removed, preventing vacuum injury to the mucosa. The pharyngeal lumen 530 can be the third lumen, and is the working lumen for suction and evacuation of fluids from the ampulla-pharyngeal drains. The pharyngeal lumen 530 has a length that extends from the proximal end of DST 500 to about the transitional zone 503. The pharyngeal lumen 530 can be terminated before reaching the transitional zone 503 (
The lower (gastric) section 501 can have a circular cross-section that is configured and dimensioned to fit and pass through the gastric-pharyngeal access channel 150 as well as the funnel-shaped distal port 171 of the ampulla. As an example, the lower section 501 can have diameter of approximately four (4) millimeters (
Referring to
As shown in
Referring to
With reference to
At step 708, before or immediately after initiation of positive ventilation, the DST is advanced further through the gastric-pharyngeal access channel, the ampulla and the distal port and its valve into the esophagus and stomach of the patient until resistance is met, that is, until the cone-shaped transitional zone of the DST engages the funnel-shaped distal port 171 of the ampulla. The engagement between the transitional zone and the funnel-shaped distal port can provide a relatively secure position for the DST, while an easy passage of the DST generally indicates adequate placement of the airway device. At this point, the DST 400 or 500 is in fluid communication with the stomach through the gastric eyelets of the gastric lumen. At step 710, suction is applied to evacuate the stomach through the DST using vacuum to the proximal end of the gastric lumen. Adequate placement and effective ventilation via the airway device should be confirmed using the conventional method such as assessing airway compliance, minimal leak pressure, and the capnography waveform. Visual confirmation with a flexible bronchoscope through the airway channel may be used if indicated. If the seal is inadequate, a small amount of air is added to the cuff to achieve optimal seal; otherwise, the airway device is removed and replaced. During ventilation, air leak from the airway device into the stomach may be vented through the DST, preventing gastric insufflation. Gastric regurgitation may be monitored and evacuated through the DST as well. Further and subsequent steps should be followed and are described in the following paragraphs.
After evacuation of residual gastric fluid or content with suction through the gastric lumen, the DST can be left in place or removed, depending on the airway device used and clinical indications. For airway device 30, which has the gastric-pharyngeal access channel 150 but no pharyngeal suction channel 140, the DST should be kept in place for evacuation of the ampulla-pharyngeal drains through the pharyngeal eyelets of the DST as described herein. However, for airway device 10 or 10′, which has the gastric-pharyngeal access channel 150 and the pharyngeal suction channel 140, the DST can be left in place for further monitoring and evacuation of gastric fluid during the surgery, and for evacuation of ampulla-pharyngeal drains as a back-up system for the pharyngeal suction channel 140; or the DST can be removed if there is no further indication or need for monitoring and evacuation of gastric fluid. Once the DST is removed, the tri-leaflets valve of the distal port can block or retard the fluid flowing from the ampulla into the esophagus while still allowing for air vent out of the esophagus-stomach, and the ampulla-pharyngeal drains can be accessed and evacuated through the pharyngeal suction channel 140. Removing the DST allows more space for surgical access to the oral cavity which may benefit surgical access to the oral airway.
If the dual section tube (DST) 400 is being used, the suction lumen 410 is separated from (i.e., not in fluid communication with) the ampulla-pharyngeal drains because the pharyngeal eyelets 412 in the cone-shaped transitional zone are blocked by the sidewall of the distal port 171 (
At step 808, before or immediately after initiation of positive ventilation, the DST is advanced further through the gastric-pharyngeal access channel and the ampulla (including the distal port and its valve) into the esophagus and stomach of the patient until resistance is met, that is, until the cone-shaped transitional zone of the DST engages the funnel-shaped distal port 171 of the ampulla. The engagement between the transitional zone and the funnel-shaped distal port can provide a relatively secure position for the DST, while an easy passage of the DST generally indicates adequate placement of the airway device. At this point, the DST 400 or 500 is in fluid communication with the stomach through the gastric eyelets of the gastric lumen. At step 810, suction is applied to evacuate the stomach through the DST using vacuum to the proximal end of the gastric lumen. Adequate placement and effective ventilation via the airway device should be confirmed using the conventional method such as assessing airway compliance, minimal leak pressure, and the capnography waveform. Visual confirmation with a flexible bronchoscope through the airway channel may be used if indicated. If the seal is inadequate, a small amount of air is added to the cuff to achieve optimal seal; otherwise, the airway device is removed and replaced. During ventilation, air leak from the airway device into the stomach may be vented through the DST, preventing gastric insufflation. Gastric regurgitation may be monitored and evacuated through the DST as well. Further and subsequent steps should be followed and are described in the following paragraphs.
At step 812, during the surgery and upon the onset of active surgical bleeding, blood as well as secretions and surgical debris in the pharynx is intermittently evacuated with brief suction through the pharyngeal suction channel 140 via an extension catheter 145 connected to the female luer lock connector 142 of the pharyngeal suction channel. The frequency of suction may vary, depending on the amount of surgical bleeding, with the goal of preventing blood accumulation in the pharynx while also avoiding potential injury to the mucosa by continuous suction. As atmospheric air may be drawn into the system through the pharyngeal drains as well as the gastric-pharyngeal access channel, the risk of vacuum injury to the mucosa is minimized. The DST should effectively block or retard the drainage of blood from the ampulla into the esophagus, ensuring effective evacuation of blood from the pharynx through the pharyngeal suction system and preventing blood irritation to the stomach and subsequent nausea or vomiting after the surgery. If the pharyngeal suction channel 140 ceases to function properly, it can be flushed with a small amount of saline using a syringe attached to the female luer lock connector 142 to clear the blockage. Otherwise, the DST 400 can be withdrawn slightly from the airway device to unseal the pharyngeal eyelets 412 (as shown in
At step 910, when the transitional zone 503 is engaged with the distal port 171 of the ampulla, the DST 500 is in fluid communication with the stomach through its gastric lumen 510 and gastric eyelets 511, and also in fluid communication with ampulla-pharyngeal drains through the pharyngeal lumen 530 and the eyelets 531 that are located above the transitional zone and positioned in the ampulla (as shown in
Unlike airway devices 10, 10′, and 30, the airway devices 20 and 20′ can and should be used alone, and cannot be used with the DST since they do not have a gastropharyngeal access channel to accommodate the DST. In an exemplary application, referring to
In describing exemplary embodiments, specific terminology is used for the sake of clarity. For purposes of description, each specific term is intended to at least include all technical and functional equivalents that operate in a similar manner to accomplish a similar purpose. Additionally, in some instances where a particular exemplary embodiment includes a plurality of system elements, device components or method steps, those elements, components or steps may be replaced with a single element, component or step. Likewise, a single element, component or step may be replaced with a plurality of elements, components or steps that serve the same purpose. Moreover, while exemplary embodiments have been shown and described with references to particular embodiments thereof, those of ordinary skill in the art will understand that various substitutions and alterations in form and detail may be made therein without departing from the scope of the invention. Further still, other aspects, functions and advantages are also within the scope of the invention.
Exemplary flowcharts are provided herein for illustrative purposes and are non-limiting examples of methods. One of ordinary skill in the art will recognize that exemplary methods may include more or fewer steps than those illustrated in the exemplary flowcharts, and that the steps in the exemplary flowcharts may be performed in a different order than the order shown in the illustrative flowcharts.
Claims
1. A laryngeal mask airway system, the system comprising:
- an airway channel portion including an airway channel; and
- a mask portion operatively coupled to the airway channel portion via an airway channel-mask junction, the mask portion including a mask, a gastric-pharyngeal access channel, and an ampulla,
- the ampulla is disposed proximate to a distal end on a back of the mask portion and includes a plurality of ports, wherein a first port of the plurality of ports is a largest one of the plurality of ports,
- the gastric-pharyngeal access channel extends upward within the back of the mask portion from the first port to an opening at which the gastric-pharyngeal access channel terminates on the back of the mask portion at a proximal end of the mask portion in proximity to the airway channel-mask junction.
2. The system of claim 1, further comprising a ramp on the mask sloping towards the opening of the gastric-pharyngeal access channel.
3. The system of claim 1, wherein a second port of the plurality of ports of the ampulla is opposingly spaced from the first port and opens towards an esophagus of a human when the mask portion is placed in the hypopharynx of the human.
4. The system of claim 3, wherein a distal end of the second port includes a valve.
5. The system of claim 4, wherein the valve is formed by a plurality of leaflets.
6. The system of claim 4, wherein in a closed position, adjacent ones of the plurality of leaflets engage each other to form a center opening.
7. The system of claim 3, wherein the second port is a funnel-shape having first cross-sectional dimensions at the ampulla and second cross-sectional dimensions at a distal end of the second port.
8. The system of claim 7, wherein a first cross-sectional area of the second port at the ampulla is greater than the second cross-sectional area of the second port at the distal end of the second port.
9. The system of claim 8, wherein the gastric-pharyngeal access channel has a third cross-sectional area that is greater than the second cross-sectional area of the second port.
10. The system of claim 1, further comprising:
- at least one pharyngeal drain formed on the mask, the at least one pharyngeal drain being operatively coupled to a third port of the plurality of ports of the ampulla.
11. The system of claim 1, further comprising:
- a pharyngeal suction channel that extends from a proximal end of the airway channel portion to a fourth port of the plurality of ports of the ampulla.
12. The system of claim 11, wherein a first portion of the pharyngeal suction channel is formed within the airway channel and a second portion of the pharyngeal suction channel is formed within the mask.
13. The system of claim 11, wherein a first portion of the of the pharyngeal suction channel is formed outside the airway channel along the airway channel portion and a second portion of the pharyngeal suction channel is formed within the mask.
14. The system of claim 1, wherein the gastric-pharyngeal access channel has an oval cross-sectional shape.
15. The system of claim 1, further comprising:
- a dual suction tube having a lower section, an upper section, and a transitional zone between the lower and upper sections.
16. The system of claim 15, wherein a distal end of the lower section includes at least one eyelet.
17. The system of claim 15, wherein the transitional zone includes at least one eyelet.
18. The system of claim 15, wherein a proximal end of the transitional zone is larger than a distal end of the transitional zone.
19. The system of claim 15, wherein a second port of the plurality of ports of the ampulla is opposingly spaced from the first port and opens towards an esophagus of a human when the mask portion is placed in the hypopharynx of the human, and
- wherein the lower section of the dual suction tube is configured and dimensioned to be inserted in and passed through the gastric-pharyngeal access channel, the first port, the ampulla, and the second port.
20. The system of claim 19, wherein the second port is a funnel-shape having first cross-sectional dimensions at the ampulla and second cross-sectional dimensions at a distal end of the second port, and
- wherein the transitional zone is configured and dimensioned to be inserted in and passed through the gastric-pharyngeal access channel, the first port, and the ampulla, and the transitional zone is configured and dimensioned to engage the second port, which is configured and dimensioned to prevent the transitional zone from passing through,
- wherein the dual suction tube is configured and/or dimensioned to be inserted into the mask portion via the gastric-pharyngeal channel until the transitional zone engages the second port of the ampulla and stops the advancement of the dual suction tube.
21. The system of claim 20, wherein the second port is configured and dimensioned to prevent the transitional zone from passing through the second port.
22. The system of claim 21, wherein the dual suction tube is configured and dimensioned to be inserted into the mask portion until the transitional zone engages the second port.
23. The system of claim 21, wherein at least one eyelet is disposed near the distal end of the transitional zone and the at least one eyelet is blocked when the transitional zone is engaged with the second port.
24. The system of claim 15, wherein the dual suction tube includes an inner lumen that forms an air vent.
25. The system of claim 15, wherein the dual suction tube includes a gastric lumen and a pharyngeal lumen.
26. The system of claim 15, wherein the gastric lumen extends a length of the dual suction tube and the pharyngeal lumen extends from a proximal end of the dual suction tube to the transitional zone.
27. The system of claim 15, wherein the pharyngeal lumen includes at least one eyelet disposed at a distal end of the pharyngeal lumen which is configured to be positioned in the ampulla when the dual suction tube is inserted into the mask portion and the transitional zone is engaged with the second port of the ampulla.
28. An airway system, the system comprising:
- a laryngeal mask including: an airway channel portion; and a mask portion, the mask portion including a gastric-pharyngeal access channel and an ampulla, the gastric-pharyngeal access channel extending upward within a back of the mask portion from a first port of the ampulla to an opening at which the gastric-pharyngeal access channel terminates on the back of the mask portion at a first end of the mask portion in proximity to an airway channel-mask junction, the ampulla being disposed proximate to a second end on the back of the mask portion and including a second port that is opposingly spaced relative to the first port, the second port being funnel-shaped, wherein the first port is greater than the second port; and
- a dual suction tube including: a lower section including at least one eyelet disposed at a distal end of the dual suction tube; an upper section including at least one port configured to be connected to a vacuum source; and a transitional zone disposed between the lower section and upper section,
- wherein the dual suction tube is configured and dimensioned to be inserted into the gastric-pharyngeal access channel passed the gastric-pharyngeal access channel, the first port, the ampulla into the second port until the transitional zone engages the second port which is configured and dimensioned to prevent the transitional zone from passing through the second port such that the dual suction tube is operable to evacuate fluids from a pharynx via the transition zone and to evacuate fluids from a stomach via the lower section when the mask portion is placed in the hypopharynx of the human.
29. The system of claim 28, wherein the transitional zone includes at least one eyelet and the at least one eyelet is blocked by the second port when the transitional zone engages the second port.
30. The system of claim 29, wherein the dual suction tube is configured to be withdrawn a specified distance from the mask portion to disengage the transitional zone from the second port and to align the at least one eyelet of the transitional zone with the ampulla to place the dual suction tube in fluid communication with the ampulla.
31. The system of claim 30, wherein the mask portion of the airway device includes pharyngeal drains formed on the mask, the pharyngeal drains being in fluid communication with the ampulla.
32. The system of claim 28, further comprising:
- a pharyngeal suction channel formed in the airway channel portion and the mask portion, wherein the pharyngeal suction channel includes a port at a proximal end of the laryngeal mask and terminates at a third port of the ampulla.
33. The system of claim 28, wherein the dual suction tube includes:
- a gastric lumen that extends a length of the dual suction tube; and
- a pharyngeal lumen that extends from a proximal end of the dual suction tube to the transitional zone.
34. The system of claim 33, wherein the pharyngeal lumen includes at least one eyelet disposed at a distal end of the pharyngeal lumen in proximity to the transitional zone.
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Type: Grant
Filed: Feb 20, 2019
Date of Patent: Feb 21, 2023
Patent Publication Number: 20200261676
Assignee: (Guilford, CT)
Inventor: Gary Zhou (Guilford, CT)
Primary Examiner: Colin W Stuart
Assistant Examiner: Matthew D Ziegler
Application Number: 16/280,107
International Classification: A61M 16/04 (20060101); A61B 1/267 (20060101); A61M 25/02 (20060101); A61M 25/00 (20060101); A61M 27/00 (20060101);